MAUDE Adverse Event Report: ANGIOSCORE, INC. ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX); CATHETER, ANGIOPLASTY, CORONARY

Model Number 2200-2515

Device Problems Break (1069); Difficult to Remove (1528); Inadequacy of Device Shape and/or Size (1583)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 02/17/2015

Event Type  Injury  

Event Description

The physician accessed the right groin through the destination sheath to the left leg to treat the dp lesion.The physician chose an angiosculpt rx 2200-2515 to treat a short lesion since the hospital does not carry the angiosculpt otw 2039-2520.The physician felt that the angiosculpt otw 2039-2540 was too long.(the total working length of the rx is only 137 cm vs 155 cm on the otw 2039.) after insertion, it was found that it was not long enough to reach the lesion.Upon removal, the balloon ¿snapped¿ off and remained in the patient, inside the sheath.The physician then inserted a 0.018¿ guide wire through the sheath and was able to remove the sheath over this wire with the angiosculpt balloon.A short sheath was then placed in the groin and the procedure ended.The lesion remained untreated.

Manufacturer Narrative

During withdrawal, the angiosculpt device separated in the sheath.Additional intervention was required for removal, thus resulting in prolongation of the case.The angiosculpt device was returned in two pieces.The device separated at the intermediate shaft approximately 80 mm from the lacerated rx port.The intermediate shaft is necked and stretched at the separated ends and the hypotube is kinked.Based on the lab analysis, it is probable that the user applied some degree of force, resulting in the device separation.Per the ifu, retained device component is listed as a possible adverse effect of the procedure.In addition, the device was used off-label in the peripheral.The angiosculpt catheter is indicated for use in the treatment of hemodynamically significant coronary artery.Placeholder.

• Brand Name: ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX)
• Type of Device: CATHETER, ANGIOPLASTY, CORONARY
• Manufacturer (Section D): ANGIOSCORE, INC.; fremont CA
• Manufacturer (Section G): ANGIOSCORE, INC.
• Manufacturer Contact: florie cazem ; 5055 brandin court; fremont, CA 94538 ; 510933-792
• MDR Report Key: 4587649
• MDR Text Key: 5338078
• Report Number: 3005462046-2015-00008
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2017
• Device Model Number: 2200-2515
• Device Catalogue Number: 2200-2515
• Device Lot Number: F14030020
• Other Device ID Number: M3702200251515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK MFG. 0.014" GUIDE WIRE; TERUMO- 6F DESTINATION SHEATH
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Weight: 82